Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04951778
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-06-23
Brief Title:
Study to Evaluate Safety and Tolerability of CC-91633 BMS-986397 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 1 Open-label Dose-finding Study of CC-91633 BMS-986397 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study CC-91633-AML-001 is a Phase 1 open-label dose escalation and expansion first-in-human FIH clinical study of CC-91633 BMS-986397 in participants with relapsed or refractory acute myeloid leukemia RR AML or in participants with relapsed or refractory higher-risk myelodysplastic syndromes RR HR-MDS The Dose Escalation part Part A of the study will enroll participants with RR AML and RR HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 BMS-986397 administered orally and determine the maximum tolerated dose MTD or preliminary recommended Phase 2 doses RP2D and schedule Throughout the study final decisions on dose escalationde-escalation will be made by the safety review committee SRC Approximately 60 participants may be enrolled in Part A of the study
The expansion part Part B will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development Approximately 60 response-evaluable subjects per indication RR AML or RR HR-MDS may be enrolled
Parts A and B will consist of 3 periods Screening Treatment and Follow-up
The expansion part Part B will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development Approximately 60 response-evaluable subjects per indication RR AML or RR HR-MDS may be enrolled
Parts A and B will consist of 3 periods Screening Treatment and Follow-up
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005329-95 | EUDRACT_NUMBER | None | None |